Recruiting

Observational Study

Sponsor:

University of Colorado, Denver

Code:

NCT05454969

Conditions

Literacy

Burden, Caregiver

Health Care Utilization

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

One-4-ALL Initiative

Control

Study Details

Brief summary:

This study aims to improve health outcomes of individuals and populations, enhance the patient experience, reduce the per capita cost of care, and ensure the well-being of our healthcare providers (quadruple aim). These goals are increasingly difficult to achieve, given the challenges of changes to workflow, staffing shortages, and increased costs brought on by the COVID-19 pandemic. Further, the pandemic brought to light the critical need to transform healthcare access for our racially and culturally minoritized and low-income families that have long been victims of health disparities, specifically with poorer health outcomes.

Conditions

Literacy

Burden, Caregiver

Health Care Utilization

Study ID

NCT05454969

Start date

Sep 1, 2023

Status verified date

Sep, 2024

Completion date

Dec 30, 2025

Anticipated

Primary completion date

Dec 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • All guardians of patients and the providers (surgeons, doctors, nurses, etc) that serve these patients.

Exclusion Criteria:

  • None.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

active comparator: One-4-ALL Initiative

The health app arm will pilot the intervention and key outcome measures will be compared between the Health App group and the placebo control.

placebo comparator: Control

Will receive standard care.

Interventions

One-4-ALL Initiative

We can successfully implement a patient app that will be used by families to 1) increase throughput for all patients, including minoritized, low-income, and low health literacy patients, and 2) reduce administrative burdens on providers.

Control

Patients will receive standard of care.

Primary outcome measure

  • Health care quality [ Time Frame: post-intervention (12 weeks) ]
  • Provider satisfaction [ Time Frame: post-intervention (12 weeks) ]
  • Patient satisfaction [ Time Frame: post-intervention (12 weeks) ]
  • Acceptability of program tool [ Time Frame: post-intervention (12 weeks) ]

Central Contacts and Locations

Central contacts

Jill Landsbaugh Kaar, PhD

17207773571jill.kaar@cuanschutz.edu

Locations

Children's Hospital Colorado

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Jill Landsbaugh Kaar, PhD

720-777-3571jill.kaar@cuanschutz.edu

More Information

Sponsor

University of Colorado, Denver

Last update posted

Oct 1, 2024

Last verified

Sep, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2024-10-01.